BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 2120480 · Received May 31, 2011

    Report

    Report Number
    1416891-2011-00004
    Event Type
    Other
    Date Received
    May 31, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT A CUT ACROSS THE OUTER SEAL OF THE BAG FOR A LENGTH OF APPROX 1 INCH. THE TEAR CHANGES DIRECTION FOR A SHORT SECTION, THEN TEARS ACROSS THE BAG FOR A LENGTH OF JUST OVER ONE INCH. THIS CHANGE IN DIRECTION IS INDICATIVE OF CUT TO TEAR. THE OUTER SEAL OF THE BAG WHEN TESTED IN PRODUCTION HAS AN AVERAGE PULL TO DESTRUCT TEST OF BETWEEN 20 TO 24 LBS. THERE WAS A SMALL CUT MADE IN THE OUTER SEAL, WHICH CONTRIBUTED TO AND ALLOWED THE MATERIAL TO TEAR. NOTE: BECAUSE AN MDR WAS NOT INITIATED VIA MEDWATCH WITHIN THE 30-DAY TIME LINE, ANCHOR PRODUCTS IS SUBMITTING THIS MDR AFTER THE FACT.

    Description of Event or Problem · 1

    CUSTOMER INCIDENT REPORT FORM INDICATES: "BAG RIPPED WHILE IN USE OF REMOVING AN ECTOPIC PREGNANCY." NO OTHER REPORTABLE INFO REGARDING THE INCIDENT WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 Q69N

    Patients

    Seq Age Sex Outcome Treatment
    1